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A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)

NCT04636801 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4710

Last updated 2025-12-17

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.

Conditions

Interventions

DRUG

Experimental: CHF6001 1600µg

CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg).

DRUG

Experimental: CHF6001 3200µg

CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg).

DRUG

Placebo

CHF6001 matching placebo, 2 inhalations bid.

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Klaus F. Rabe, Prof. · LungenClinic Grosshansdorf GmbH Wöhrendamm 80 22927 Großhansdorf GERMANY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-14
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • United States
  • Albania
  • Argentina
  • Australia
  • Austria
  • Bosnia and Herzegovina
  • Bulgaria
  • Chile
  • China
  • Czechia
  • Georgia
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • New Zealand
  • North Macedonia
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04636801 on ClinicalTrials.gov